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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Intraoperative Orthopedic Joint Assessment Aid
510(k) Number K193580
Device Name VERASENSE for Zimmer Biomet Persona CR C-D/3-9 Left, VERASENSE for Zimmer Biomet Persona CR C-D/3-9 Right, VERASENSE for Zimmer Biomet Persona CR E-F/3-11 Left, VERASENSE for Zimmer Biomet Persona CR E-F/3-11 Right, VERASENSE for Zimmer Biomet Persona CR G-H/7-12 Left
Applicant
Orthosensor, Inc.
1855 Griffin Rd. Suite A-310
Dania Beach,  FL  33004
Applicant Contact Deborah Johnson
Correspondent
Orthosensor, Inc.
1855 Griffin Rd. Suite A-310
Dania Beach,  FL  33004
Correspondent Contact Deborah Johnson
Regulation Number882.4560
Classification Product Code
ONN  
Subsequent Product Code
OLO  
Date Received12/23/2019
Decision Date 04/01/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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